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510(k) K203827

REMI by Epitel, Inc. — Product Code OMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2021
Date Received
December 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reduced- Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes

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